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NCT03013751 · ClinicalTrials.gov registry record · Phase 3
A Extension Study of Udenafil in Adolescents
A Phase 3 study of Functional Single Ventricle Heart Disease, sponsored by Mezzion Pharma Co..
- Completed
- Registry status
- Phase 3
- Development phase
- 301
- Enrollment target
- 20
- Study locations
NCT03013751 is a Phase 3 study of Functional Single Ventricle Heart Disease that has completed, run by Mezzion Pharma Co.. The registered enrollment target is 301 participants. The trial reports 20 study locations across 18 states.
The verdict
NCT03013751, a Phase 3 study of Functional Single Ventricle Heart Disease, has completed, sponsored by Mezzion Pharma Co..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 301 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart disease.
Conditions Studied
Interventions
- DRUG Udenafil
Study Locations (20)
California
- Cedars/Sinai Heart Institute - Los Angeles
- Rady Children's Hospital - San Diego
Missouri
- Children's Mercy Hospital Kansas City - Kansas City
- Washington University St. Louis/St.Louis Children's Hospital - St Louis
Arizona
- Phoenix Children's Hospital/Children's Heart Center at Phoenix Children's Hospital - Phoenix
Colorado
- Children's Hospital Colorado - Aurora
Delaware
- Nemours Cardiac Center/Alfred I. duPont Hospital for Children - Wilmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- Johns Hopkins All Children's Heart Institute - St. Petersburg
Georgia
- Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2017-02-06 |
| Est. Completion | 2022-12-20 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03013751
The ClinicalTrials.gov registry entry for NCT03013751 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 301 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mezzion Pharma Co., which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Functional Single Ventricle Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which Udenafil is the first listed.
NCT03013751 reports 20 study locations spanning 18 distinct geographic areas - top geographies include California, Missouri, Arizona.
Frequently Asked Questions
What is clinical trial NCT03013751 about?
NCT03013751 is a clinical study titled "A Extension Study of Udenafil in Adolescents". This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart disease.
What is the current status of trial NCT03013751?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 301 participants. The study started on 2017-02-06. Estimated completion is 2022-12-20.
What conditions does trial NCT03013751 study?
This clinical trial studies the following conditions: Functional Single Ventricle Heart Disease.
What interventions are being tested in trial NCT03013751?
The interventions under investigation include: Udenafil (DRUG).
Who is sponsoring clinical trial NCT03013751?
This trial is sponsored by Mezzion Pharma Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03013751 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.